Covid19NCT04847349
Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
A study testing OL-1, standard dose and OL-1, high dose in people with Covid19, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- OL-1, standard dose and OL-1, high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (any gender, ages 18 to 60 years old) in good general health, based on medical history
- SARS-CoV-2 infection >4 months prior confirmed by a positive polymerase chain reaction (PCR) or antigen test
- Body mass index (BMI) of 18.5-39.9 kg/m2
- Agreement to comply with the protocol and study restrictions
- Access to internet in addition to willingness and ability to use web-based questionnaires
- Available for all study visits
- English-speaking
Who cannot join
- Recent infection with coronavirus disease-2019 (COVID-19) (newly positive PCR or antigen test within prior 4 months)
- Prior receipt of antibody therapies (convalescent or monoclonal) towards COVID-19
- Prior receipt of vaccines against COVID-19
- Prior or current participation in a clinical trial of vaccines against COVID-19
- Scheduled to receive a vaccine against COVID-19 in the following month
- Regular use of any live microbial (probiotic) supplements
Show all 13Show fewer
- Any acute or chronic respiratory tract disease besides mild to moderate asthma
- Any diagnosed immunodeficiency
- Current use of immunosuppressive drugs
- Any diagnosis of chronic gut disease, such as inflammatory bowel disease or irritable bowel syndrome
- Pregnancy or breastfeeding
- Recent use of antibiotics
- Current addiction to alcohol, drugs, or medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial)
This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.
Read the detailed description
This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses (a standard dose and a high dose) of a combination of live microbials (probiotics), currently marketed in food (including products labeled as dietary supplements), given daily for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with prior confirmed SARS-CoV-2 infection. Data collected will include demographics, comorbidities, medications, information about prior SARS-CoV-2 infection, and self-reported symptoms and adverse events (AEs). Biospecimens (saliva, nasal wash, blood, and stool) will be collected at baseline and days 21 and 42 for analysis.
- Conditions
- Covid19
- Being tested
- OL-1, standard dose, OL-1, high dose, Placebo
- Keywords
- Probiotics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OL-1, standard doseDietary supplement
The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.
OL-1, high doseDietary supplement
The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.
PlaceboDietary supplement
Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Live microbial (Probiotic) consortium OL-1, standard dose | Experimental | Combination of a standard dose of live microbials (probiotics) taken as a capsule once per day with breakfast for 21 days. Capsules should not be consumed with hot drinks or alcohol. Receives: Dietary Supplement: OL-1, standard dose |
| Live microbial (Probiotic) consortium OL-1, high dose | Experimental | Combination of a high dose of live microbials (probiotics) taken as a capsule once per day with breakfast for 21 days. Capsules should not be consumed with hot drinks or alcohol. Receives: Dietary Supplement: OL-1, high dose |
| Placebo for live microbial (probiotic) consortium | Placebo comparator | Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG)
Measured: between baseline and day 21 (day 1 is the first day of taking the investigational product)
Secondary outcomes (8)
Change in the titer of serum anti-SARS-CoV-2 IgG
Measured: between baseline and day 42
Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody
Measured: between baseline and days 21 and 42
Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody
Measured: between baseline and days 21 and 42
In-vitro changes in cytokine release in response to stimulation of peripheral blood mononuclear cells with SARS-CoV-2 peptides
Measured: between baseline and days 21 and 42
Serum cytokine levels
Measured: between baseline and days 21 and 42
Adverse events
Measured: up to 10 weeks
Change in any baseline symptoms from prior SARS-CoV-2 infection
Measured: up to 6 weeks
New (repeat) SARS-CoV-2 infections
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start13 Apr 2021
- Primary completion1 Nov 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Vault Health, Inc., Danisco USA Inc.
- Responsible party
- Principal investigator, Daniel B. Horton, MD, MSCE, Rutgers, The State University of New Jersey
- Investigators
- Daniel B Horton, MD, MSCE, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847349
- Sponsor's protocol ID
- Pro2021000186
- Status last verified
- Jan 2022
- First submitted
- 13 Apr 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Saliva, nasal rinse, blood samples, and stool samples collected will be used for the purposes of this research. After information that could identify consenting participants has been removed, de-identified information and left over biospecimens collected for this research may be used by or distributed to the study funder (Danisco USA Inc.) or to investigators for other research without obtaining additional informed consent. Personal identifying details, such as name and date of birth, will not be shared without participants' additional permission.
Publications
Horton DB, Ukey R, Madhvi A, Andrews T, Parmar V, Reilly N, Makela SM, Peterson J, Hustad L, Wong G, Barrett ES, Bruiners N, Carson JL, Getz K, Greenberg P, Iizuka A, Roy J, Pastuszak AW, Lehtinen MJ, Blaser MJ, Panettieri RA Jr, Gennaro ML. Live microbials to boost Anti-SARS-CoV-2 immunity clinical trial (Live BASIC trial): a triple-blind randomized controlled trial. Infection. 2026 Feb;54(1):473-485. doi: 10.1007/s15010-025-02697-4. Epub 2025 Nov 26.
PubMed 41299123
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Microbials to Boost Anti-SARS-CoV-2 Immunity Clinical Trial (Live BASIC Trial)
- ClinicalTrials.gov ID
- NCT04847349
- Acronym / sponsor ID
- Pro2021000186
- Conditions
- Covid19
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Vault Health, Inc., Danisco USA Inc.
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses of a combination of live microbials (probiotics) given to boost the immunity of unvaccinated persons previously infected with SARS-CoV-2.
Detailed description
This pilot double-blind randomized controlled trial will test the preliminary efficacy of two doses (a standard dose and a high dose) of a combination of live microbials (probiotics), currently marketed in food (including products labeled as dietary supplements), given daily for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with prior confirmed SARS-CoV-2 infection. Data collected will include demographics, comorbidities, medications, information about prior SARS-CoV-2 infection, and self-reported symptoms and adverse events (AEs). Biospecimens (saliva, nasal wash, blood, and stool) will be collected at baseline and days 21 and 42 for analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Live microbial (Probiotic) consortium OL-1, standard dose | Experimental | Dietary Supplement: OL-1, standard doseCombination of a standard dose of live microbials (probiotics) taken as a capsule once per day with breakfast for 21 days. Capsules should not be consumed with hot drinks or alcohol. |
| Live microbial (Probiotic) consortium OL-1, high dose | Experimental | Dietary Supplement: OL-1, high doseCombination of a high dose of live microbials (probiotics) taken as a capsule once per day with breakfast for 21 days. Capsules should not be consumed with hot drinks or alcohol. |
| Placebo for live microbial (probiotic) consortium | Placebo comparator | Dietary Supplement: PlaceboCapsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics, taken once per day with breakfast for 21 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults (any gender, ages 18 to 60 years old) in good general health, based on medical history
- SARS-CoV-2 infection >4 months prior confirmed by a positive polymerase chain reaction (PCR) or antigen test
- Body mass index (BMI) of 18.5-39.9 kg/m2
- Agreement to comply with the protocol and study restrictions
- Access to internet in addition to willingness and ability to use web-based questionnaires
Key exclusion criteria (13 listed)
- Recent infection with coronavirus disease-2019 (COVID-19) (newly positive PCR or antigen test within prior 4 months)
- Prior receipt of antibody therapies (convalescent or monoclonal) towards COVID-19
- Prior receipt of vaccines against COVID-19
- Prior or current participation in a clinical trial of vaccines against COVID-19
- Scheduled to receive a vaccine against COVID-19 in the following month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OL-1, standard doseThe live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States. | Dietary supplement | Live microbial (Probiotic) consortium OL-1, standard dose |
| OL-1, high doseThe live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States. | Dietary supplement | Live microbial (Probiotic) consortium OL-1, high dose |
| PlaceboCapsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics. | Dietary supplement | Placebo for live microbial (probiotic) consortium |
Primary outcome
Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG)
Time frame: between baseline and day 21 (day 1 is the first day of taking the investigational product)
8 secondary outcomes
Change in the titer of serum anti-SARS-CoV-2 IgG
Time frame: between baseline and day 42
Change in the titer of serum anti-SARS-CoV-2 neutralizing antibody
Time frame: between baseline and days 21 and 42
Change in the titer of serum and nasal anti-SARS-CoV-2 immunoglobulin A (IgA) antibody
Time frame: between baseline and days 21 and 42
In-vitro changes in cytokine release in response to stimulation of peripheral blood mononuclear cells with SARS-CoV-2 peptides
Time frame: between baseline and days 21 and 42
Serum cytokine levels
Time frame: between baseline and days 21 and 42
Adverse events
Time frame: up to 10 weeks
Change in any baseline symptoms from prior SARS-CoV-2 infection
Time frame: up to 6 weeks
New (repeat) SARS-CoV-2 infections
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 41299123Horton DB, Ukey R, Madhvi A, Andrews T, Parmar V, Reilly N, Makela SM, Peterson J, Hustad L, Wong G, Barrett ES, Bruiners N, Carson JL, Getz K, Greenberg P, Iizuka A, Roy J, Pastuszak AW, Lehtinen MJ, Blaser MJ, Panettieri RA Jr, Gennaro ML. Live microbials to boost Anti-SARS-CoV-2 immunity clinical trial (Live BASIC trial): a triple-blind randomized controlled trial. Infection. 2026 Feb;54(1):473-485. doi: 10.1007/s15010-025-02697-4. Epub 2025 Nov 26.
- Individual participant dataSharing planned: Yes. Saliva, nasal rinse, blood samples, and stool samples collected will be used for the purposes of this research. After information that could identify consenting participants has been removed, de-identified information and left over biospecimens collected for this research may be used by or distributed to the study funder (Danisco USA Inc.) or to investigators for other research without obtaining additional informed consent. Personal identifying details, such as name and date of birth, will not be shared without participants' additional permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Horton, MD, MSCE principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OL-1, standard dose and OL-1, high dose in people with Covid19, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in titer of serum anti-SARS-CoV-2 immunoglobulin G (IgG) (time frame: between baseline and day 21 (day 1 is the first day of taking the investigational product)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.